SGS to operate Ph I inpatient clinical trials at Budapest hospital
The agreement with the Medical Center of Defense Forces Hospital further expands the company’s embedded hospital clinical pharmacology network.
The clinical and bioanalytical contract solutions provider also has facilities in Antwerp and Mechelen, Belgium.
"Eastern Europe, and Hungary specifically, is a great place to reach naive patients and having this unit creates a win-win partnership between local experts and the hospital," Florent Hediard at SGS Life Science told Outsourcing-Pharma.com.
"This ensures full control and oversight of clinical trials to guarantee the study trial quality, compliance with international rules, scientific exchanges between SGS and the hospital staff, and access for local patients to the latest treatments."
As part of the agreement, the hospital dedicated some of its facilities and SGS invested in the equipment and local staff to maintain and manage the unit.
The new patient unit is located in a secured wing close to the intensive care unit and will feature five hospitalization beds. It is also equipped with an examination room, a sample preparation area, a sample storage area/locker, and restrooms.
A permanent, on-site SGS team will conduct the early phase trials in collaboration with hospital physicians, trial experts, and investigators.
"There is an on going clinical trial within this hospital for an oncology treatment," Hediard explained. "SGS will use this new phase I unit to coordinate other 'sister' units within other hospitals with a local/close direct support."
ISO 13485:2016
SGS has also announced that it has been granted accreditation for ISO 13485:2016, following a transition assessment done by United Kingdom Accreditation Service (UKAS).
According to the International Organization for Standardization (ISO), ISO 13485:2016 “specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
